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The Restoration Acetabular Wedge Augments are intended for use as an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.

General Indications for Total Hip Replacement Components:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or . other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive . techniques as indicated by deficiencies of the acetabulum.

Indications Specific to the Acetabular Wedges:

• As an alternative to structural allograft in cases of superior and superior/posterior . segmental acetabular deficiencies.
  Acetabular Augments are intended for cementless use only to the bone interface; and 2) are affixed to the mating cup using bone cement

Restoration Acetabular Wedge Augments provide options to address a wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects. The augments are offered in various geometries and sizes to address wide defect ranges. The augments are made of commercially pure titanium porous sintered foam. The Restoration Acetabular Wedge Augments can be used with Restoration ADM, Secur-Fit, Trident, and Tritanium uncemented shells. The Restoration Acetabular Wedge Augments can be used with Trident all-polyethylene cemented cups

The provided text describes a 510(k) premarket notification for the "Restoration Acetabular Wedge Augments." This submission is for a medical device that substitutes for allografts in hip reconstructive surgeries. The crucial information regarding acceptance criteria and study details is presented below, extracting from the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The submission relies on a demonstration of substantial equivalence to predicate devices rather than meeting specific performance criteria in a clinical setting. Therefore, the "acceptance criteria" are related to mechanical and material properties that demonstrate comparable safety and efficacy to existing legally marketed devices.

• Tensile strength
• Compression strength
• Construct fatigue testing (augment/shell)
• Static compression strength post-fatigue
• Abrasion post-fatigue | Performed mechanical testing according to "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Cement (28 April 1994)".
• "There was no affect on mechanical morphological properties based on fatigue loading."
• Testing demonstrated substantial equivalence to currently cleared devices. |
  | Material Properties (CP Titanium porous sintered foam):
• Volume porosity
• Average pore size
• Mean intercept length
• Grain size
• Morphological properties post-fatigue | Determined these parameters for the CP Titanium porous sintered foam.
• "There was no affect on mechanical morphological properties based on fatigue loading."
• Testing demonstrated substantial equivalence to currently cleared devices. |
  | Intended Use Equivalence:
• As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.
• Cementless use to bone interface, affixed to mating cup using bone cement. | Device comparison showed that the proposed device is substantially equivalent in intended use to the predicate devices (Zimmer Trabecular Metal Augments K061067 and Osteonics Acetabular Wedge System K971422). |
  | Material Equivalence:
• Made of commercially pure titanium porous sintered foam. | Device comparison showed that the proposed device is substantially equivalent in materials to the predicate devices. |
  | Performance Characteristics Equivalence:
• Provides support for the shell in the acetabulum with superior and/or posterior defects.
• Offered in various geometries and sizes.
• Can be used with Restoration ADM, Secur-Fit, Trident, and Tritanium uncemented shells, and Trident all-polyethylene cemented cups. | Device comparison showed that the proposed device is substantially equivalent in performance characteristics to the predicate devices. Mechanical and material testing supported this equivalence by demonstrating no adverse effects from fatigue loading and characterizing key properties of the porous foam. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document explicitly states: "Non-Clinical laboratory testing was performed..." and "Clinical testing was not required for this submission." This indicates that no human test set data was used. The testing involved mechanical and material analyses of the device itself.
• Data Provenance: Not applicable as no human data was used. The non-clinical testing would have been conducted in a laboratory setting, likely in the country of origin of the manufacturer (USA, given the address).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. No human test set requiring ground truth establishment by experts was conducted. The evaluation was based on non-clinical mechanical and material properties.

4. Adjudication Method for the Test Set

• Not applicable. No human test set requiring adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. Clinical testing was explicitly stated as "not required for this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical implant, not a software algorithm.

7. Type of Ground Truth Used

• Not applicable as no human data was used. The "ground truth" in this context would be the established engineering standards and material properties, which are used to evaluate the device against predicate devices through non-clinical testing.

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant and no AI/machine learning training set was used.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. No training set was used.

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